Anyone working in a medical laboratory setting is well aware of the essential importance of temperature-controlled environments. Almost universally, labs are required to maintain and monitor proper temperatures in their entire environment by their institutions, as well as by their respective regulatory bodies. Clearly, these requirements are largely driven by the need to ensure the integrity of testing systems and reagents, and to protect inherently valuable samples and products.
Whole-environment monitoring includes not only the temperatures and fluctuations of refrigerators and freezers, but also the ambient temperature of storage areas (for supplies and reagents) and testing areas (driven by equipment specifications for operating temperature and humidity ranges). As with any modernization of health-care related technology, striving to remain at the forefront of innovation is the ideal state. Older systems for monitoring may employ mechanisms such as wheel charts for physically graphing temperature fluctuations and may or may not have audible alarms when temperatures drift out of pre-set ranges; these functions represented the best available options for their time, but today’s devices go well beyond such rudimentary systems and can provide far superior abilities.
Scope of Temperature Monitoring
Virtually every area of a clinical lab has some type of temperature control parameters that must be followed and most (if not all) automated testing systems have temperature and humidity range parameters that must be monitored and controlled to the ranges specified for each system. Therefore, action plans and documentation of follow up corrective actions are essential to ensure that such systems are operating to specification. Even point-of-care testing occurring outside of the traditional lab setting has requirements for reagent and supply storage—both refrigerated and non-refrigerated—that require monitoring.
Fortunately, acquiring the necessary equipment to properly monitor temperatures should be an easy sell to hospital administrators given the current regulatory environment. Keep in mind that hospitals and health systems must focus on many areas and programs that require such systems, including pharmaceutical storage (both unit- and pharmacy-based), point-of-care testing, breast milk storage, patient food storage, food services storage, etc. In fact, labs may uncharacteristically be laggards in adopting new monitoring technologies and should explore what their organizations are doing with regard to this arena. Given that so many areas rely on proper temperature control, an automated, systemic approach has many advantages, not the least of which is protection against asset losses.
Temperature monitoring has been a vital component of lab operations for a long time, but often such systems were pieced together from disparate sources and were difficult to reconcile. Prior to our recent implementation of a comprehensive, wireless temperature monitoring system, we employed locally audible and wired remote alarms for blood products storage, temperature charts on both alarmed and unalarmed refrigerators, log books for single point-in-time monitoring, and so-called continuous monitoring and storage of temperature and humidity data, without alarms. The gaping holes in these processes that hampered timely responses to variations were readily apparent in these older approaches.
Now, each monitored storage unit—whether it is a refrigerator or freezer—has an internal probe and an external module for transmitting the recorded data. This data is transmitted through the hospital’s wireless network to a server with management software that is connected through the Internet to a signaling and alarming system at the host company. We monitor all lab refrigerators and freezers this way, as each probe and module assembly is inexpensive and the monitoring costs also are nominal. Specific staff members are notified of alarms by both email and pager. Another option is to have the alerts sent to a workstation where staff actually intercedes directly. Furthermore, we are able to look up temperature data points retrospectively for any time period we choose. We also have designated super users who can look at this data across departments. Designating super users ultimately depends on the lab’s management structure, complexity, and number of monitored units, as well as what makes the most sense in terms of physically covering this function. Not all range fluctuations necessarily require corrective action documentation, but with a sensitive monitoring system, even temperature spikes caused by opening a refrigerator door may drive a process change to help minimize variations.
Current Benefits and Future Capabilities
Most notably, our new wireless system allowed us to replace manual monitoring and documentation processes and provides firm reassurance of our systems’ integrity. In addition, diagnostics and repairs are invoked quickly, as failures are random and can be difficult to predict. For example, we have found that refrigerated units often do not fail completely at once; rather they tend to work through multiple episodes of partial failure before ceasing to operate altogether. Our predictive capability has increased because continuous monitoring is now available. Further, the decision to select a wireless system (as opposed to wired) was made due to the fact that our hospital already employs wireless networking for multiple systems and the bandwidth required for our system was not onerous.
Looking forward, I envision refinements in the basic software of these systems will ultimately allow us to preprogram tolerances for short term fluctuations caused by the opening and closing of doors that would not otherwise affect the integrity of the contents. The probes in use today are so sensitive that alarm fatigue is a real possibility that can lull staff into not reacting to bona fide problems. Vigilance over these systems, and preparation for emergencies remains important. We depend more and more on electronic devices for almost every activity, so a thoughtful understanding of what effects a downtime scenario would have and what back-up mechanisms would need to be in place is invaluable. Regardless, current temperature monitoring systems are quite robust, cost-effective, and secure in both surveillance and documentation to provide peace of mind about product and testing integrity.
By Robert Neri, DLM(ASCP)PACM, FACHE, is the assistant vice president of laboratory operations at Virtua Health in Voorhees, New Jersey, where he is responsible for strategic planning and all lab operations across a multi-hospital health care system. Bob earned a BS in biology from the University of Connecticut, a master of health sciences degree from Quinnipiac University, and a master of business administration with a focus on health care administration from St. Joseph’s University. Previous positions have included operations director for Main Line Clinical Labs in Radnor, Pennsylvania and director of diagnostic services at Montgomery Hospital in Norristown, Pennsylvania. Bob also is former executive vice president of the Clinical Lab Management Association (CLMA).
Special MLM Buyer’s Guide:
Temperature Monitoring Systems
The VersaTrak monitoring system proves the accuracy of every transmitter, enterprise-wide, using its Automatic NIST Calibration (ANC) technology. Any ANC wireless transmitter on the VersaTrak Enterprise 5 system can be verified through the software, eliminating the need for independent validation testing and reducing operating costs. Check one transmitter or the entire system at any time, or per scheduled testing intervals. The system tracks and records each test and will automatically notify designated staff in the event a transmitter fails. ANC is available for both Wi-Fi and 900 MHz transmitters.
VersaTrak also features the Intelligent Messaging reply function, which provides two-way communication for those alerted. When notified of an alert, any user is able to respond by simply replying to the notification; there is no need to log onto a computer in order to clear an alert or log a corrective action. As soon as a reply is received, the system will automatically clear all the remaining pop-up alerts that were originally sent.
> From Veracity Group Inc
The Web600 system provides continuous monitoring and reporting for up to six temperature sensors, which are available as metal probes or packaged inside of glass bead-filled vials. Both sensor styles are available to monitor freezers down to -85°C and NIST calibration certificates are available. The Web600 is compatible with third-party Thermistor temperature sensors and can monitor other conditions such as humidity and power failure. Immediate alarm notification for all conditions is provided via email and text message. With an optional battery backup, the system can operate for up to three hours during a power outage and data logging and trending is built in with storage for 64,000 time-stamped records. The Web600 has no software maintenance costs and no monthly fees.
> From Sensaphone
The Centron Wi-Fi System is designed to mitigate the overall adoption process, as the new line of Wi-Fi transmitters utilize existing infrastructure to minimize site impact and enable quick installation. The Wi-Fi system is available with Rees Scientific’s full line of sensors, including temperature, humidity, light, and differential pressure. It is able to accept up to four industry standard inputs, and each module can buffer up to seven days of readings history recorded at 15-minute intervals. The modules are FCC-certified and have battery back up.
> From Rees Scientific
The EDL-Net and EDL-RF2 provide remote temperature monitoring for hospitals, laboratories, and research organizations. Users can wirelessly collect, monitor, and document temperature data for multiple floors, buildings, and refrigeration rooms. With built-in connections, the EDL-Net and EDL-RF2 are ideal tools for monitoring low temperature freezers, blood, vaccines, or biologics while collecting temperature measurement data in real-time using audit trails for regulatory control. Users benefit from alarm notifications via email, phone, or pager as well as multiple alarm options. The interchangeable sensors can read temperatures from -80°C to 72°C.
The EDL-Net can be set up using Wi-Fi access or an Ethernet connection and is accessible anywhere via the Internet. The advanced software can detect temperature excursions and power outages, and send alert notifications via cell phone for facilities management to control. The EDL-RF2 has a powerful two-way 900 MHz radio for long-range wireless connectivity, and is ideal for laboratories, clinics, and facilities management. The software is 21 CFR-compliant, enables supervisory control, and allows database creation for products, dates, locations, identification numbers, statistical analysis, and more.
> From Marathon Products Inc
The i.Series Laboratory Refrigerators from Helmer include the i.C3 user interface and offer 24/7 temperature monitoring and control, multiple information logs, event acknowledgement, and report downloading via a 7-inch (177 mm) full-color touchscreen. The i.C3 user interface allows users to maintain temperature uniformity and rapid recovery after door openings. High and low temperature alarms, both audible and visual, will notify the user of any out of range conditions. Laboratories benefit from reduced condensation on boxes and other containers. Available in upright, undercounter, and pass-thru models, the i.Series is ideal for storing blood products, reagents, vaccines, or samples.
> From Helmer Scientific
The Accsense Ethernet temperature monitor is designed for use with medical refrigerators, freezers, and incubators with live remote monitoring. It has connections for two external RTD temperature probes and one thermocouple sensor. There is no software to install and in the event of a loss of network connection it will store up to 256 data points. The unit can operate on power over ethernet (POE) or on a main power unit, and is completely automated with secure data transmission and storage using SSL and certificate encryption. The Accsense A2-05 data logger offers complete flexibility in setting local and remote alarms with phone, email, and text alerts.
> From Sensaphone
The LIBERO is an independent monitoring solution used for shipment monitoring, as a simple alternative to chart recorders, or a backup to a central monitoring system. The device accommodates temperature ranges from -200°C to 200°C (+/- 0.2°C accuracy depending on range) or temperature and humidity. The LIBERO has a real-time LCD display with access to min, max, and average temperatures. Each LIBERO model has a visual alarm; however, an audible alarm bracket can be wired to a telephone dialer or in-house alarm for remote notification. The LIBERO includes a validation certificate and is 21 CFR Part 11–compliant. No software or hardware is required to download data and there are three battery life options: 100 day (common for single-use shipments), 400 day (multiuse), and three year (multiuse).
> From Elpro Services
The CompX eLock provides network–wireless 802.11g or Ethernet temperature monitoring and access control for cold storage applications. The eLock automatically logs temperature data points at predetermined times and designated staff members are notified immediately of any out-of-temperature range occurrences through the facility’s network. The CompX eLock is a keyless device, so there are no keys to lose or share. The eLock allows users secure access with existing ID cards or PIN numbers, and maintains an extensive audit trail of access attempts.
> From CompX Security Products
The PakSense BIOmed XpressPDF Label from Cold Chain Technologies is a method of monitoring and recording temperatures of blood, vaccines, pharmaceuticals, biologics, samples, and other temperature sensitive products during distribution and storage. This durable, compact surface label provides a closer approximation of actual product temperature versus general ambient readings. Calibrated to NIST standards, it generates a regulatory compliant PDF file containing complete time and temperature history, including graphs and summary data. Due to an integrated USB connection, there is no proprietary software or reader required.
> Cold Chain Technologies
Primex Wireless Synchronous Network System (SNS) temperature monitoring provides an automated approach to monitoring important refrigerated assets such as blood, tissue samples, and biologics. The Wi-Fi enabled sensor connects to a central software application over an existing wireless network to deliver temperature readings for logging, reporting, and data archiving. Available with single or dual thermistor probes, the sensor mounts outside the refrigeration unit and probes are inserted into refrigerated compartments. A built-in LCD displays real-time readings, including diagnostic information, for up to two zones. Audible and emailed alerts are generated to notify the appropriate contacts when readings go outside predefined thresholds. In the event of a power loss, each sensor contains battery backup for uninterrupted operation until power is restored.
> From Primex Wireless
The CMS-II Central Monitoring System offers comprehensive monitoring and documentation of all refrigerators and other equipment temperatures and environmental conditions. This system can meet the needs of a small laboratory, as well as allow seamless integration of facilities with multiple departments, buildings, and locations on the same network. The system is SQL-based and can operate stand-alone or be integrated into an existing IT environment. Multiple equipment groups and user groups allow for precise assignment of responsibility and authority for each monitored location. The user can define alarm set points, each point’s description, as well as procedures for alarm follow up. Custom reports can be created using off-the-shelf SQL reporting software. Notification of all alarms can be made via printer, phone or cell phone, pager, or email.
> From Hampshire Controls Corporation
CheckPoint is a laboratory monitoring system designed to comply with the stringent requirements of TJC, FDA, AABB, CAP, CLIA, and other regulatory agencies. CheckPoint monitors and safeguards all lab equipment, such as refrigerators, -80°C freezers, LN2, CO2 incubators, heat blocks, water baths, air (flow) pressure, and other laboratory applications. The system monitors vital products and samples using real-time monitoring.
CheckPoint and Fetch Real-Time Location System (RTLS) wireless systems are ideal for temperature and vital parameters monitoring, cold-chain management, and asset inventory and tracking visibility. TempSys solutions safeguard product integrity, protect and manage an organization’s vital assets, and are available with full project management, system installation, and on-site validation services.
> From TempSys
TempTrak Wireless Temperature Monitoring System version 4.5 offers 24/7 remote temperature, humidity, and open/close monitoring for sensitive laboratory storage. The system can report temperature, relative humidity, ultra-low freezer, and analog voltage data from -200°C to 260°C. TempTrak stores data indefinitely and provides real-time alerts through pop-up messages, email, voicemail, and pager alerts.
Ideally suited for clinical as well as research lab environments, TempTrak can wirelessly monitor sensitive lab storage environments, in an unlimited number of locations, with one piece of software. This advanced wireless system eliminates the need for labor-intensive manual temperature monitoring, and provides instantaneous and accurate data. TempTrak is available in both Wi-Fi and 900 MHz configurations.
> From Cooper-Atkins Corporation